Devices › Monitor, physiological, patient(with arrhythmia detection or alarms)
Device brand name · Central monitor system
Cns-9700a: medical device reports filed with FDA
393 reports name it, 2015–2022. Manufacturer given most often on reports: Nihon Kohden. Product code MHX.
- 393
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.7%
- classified as malfunction
- 82.1% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 393 reports that name the brand "Cns-9700a" (central monitor system), received between October 2015 and December 2022; the manufacturer given most often on reports is Nihon Kohden. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.7%), injury (0.5%) and other (0.5%); across all monitor, physiological, patient(with arrhythmia detection or alarms) reports (product code MHX) death is recorded in 5.9% and malfunction in 82.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device inoperable (24.9%), communication or transmission problem (16.5%) and no display/image (12.7%). The patient problems coded most often are no patient involvement, death and non specific ekg/ECG changes. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 32,636 reports carrying product code MHX. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device inoperablethe device could not be used | 98 | 24.9% | 3.6% |
| Communication or transmission problemthe device could not communicate or transmit | 65 | 16.5% | 6% |
| No display/image | 50 | 12.7% | 4.1% |
| Application program problem | 44 | 11.2% | 2.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 30 | 7.6% | 9.3% |
| Application interface becomes non-functional or program exits abnormally | 23 | 5.9% | 0.8% |
| Display or visual feedback problem | 22 | 5.6% | 3.2% |
| Unintended application program shut down | 21 | 5.3% | 1.9% |
| Device issuea problem with the device | 20 | 5.1% | 0.4% |
| Loss of powerthe device lost power | 20 | 5.1% | 1.1% |
| Output problem | 18 | 4.6% | 3.2% |
| Device displays incorrect message | 17 | 4.3% | 4.3% |
| Computer operating system problem | 16 | 4.1% | 1.9% |
| Power problem | 16 | 4.1% | 1.6% |
| No audible alarm | 15 | 3.8% | 11.5% |
| Device operational issue | 14 | 3.6% | 0.2% |
| Device alarm system | 12 | 3.1% | 8.1% |
| Device stops intermittentlythe device stopped now and then | 10 | 2.5% | 0.7% |
| Protective measures problem | 10 | 2.5% | 1.3% |
| Failure to power up | 8 | 2% | 0.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 5 | 1.3% |
| Deaththe patient died; cause not stated by this term | 2 | 0.5% |
| Non specific ekg/ECG changes | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cns-9700a | Product code MHX | All MAUDE reports |
|---|---|---|---|
| Reports | 393 | 32,636 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 59 | 9 |
| Classified as injury | 0.5% | 11.2% | 36.2% |
| Classified as malfunction | 98.7% | 82.1% | 62.3% |
| Filed by the manufacturer | 92.6% | 93.4% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MHX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Patient Information Center iX | 1,941 | 619 | 10.4% |
| uCor Heart Failure and Arrhythmia Management System | 1,877 | 762 | 0% |
| Tempus Pro | 1,850 | 108 | 0.5% |
| Cns-6201a | 1,720 | 0 | 0.8% |
| IntelliVue Multi Measurement Server X2 | 1,924 | 135 | 1.7% |
| Cns-6801a | 1,058 | 0 | 1.5% |
| Intellivue Information Center Ix | 952 | 0 | 7.5% |
| Intellivue X3 | 777 | 0 | 1.5% |
| Tempus Pro, Printer | 562 | 400 | 0% |
| Piic Ix Hardware | 538 | 0 | 4.6% |
| Xhibit Central Station | 492 | 154 | 0.8% |
| IntelliVue Multi-Measurement Module X3 | 478 | 401 | 1.7% |
| IntelliVue MX450 Patient Monitor | 448 | 123 | 7.6% |
| Pu-681ra | 437 | 222 | 1.4% |
| Arrhythmia Management System | 381 | 4 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Cns-9700a reports
How many FDA reports name Cns-9700a?
393 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%), injury (0.5%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device inoperable (24.9%), communication or transmission problem (16.5%), no display/image (12.7%), application program problem (11.2%) and device operates differently than expected (7.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (92.6%) and distributor reports (7.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cns-9700a was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.